NCT01203735Unknown1 期
Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Vinorelbine and Cisplatin for Inoperable Locally Advanced Non-Small-Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with locally advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned for three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and oral valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3 months after completion of the study treatment. Toxicity will be assessed using CTCAE, based on clinical examination and laboratory tests during the study treatment and at follow up visits. Response to treatment will be evaluated using RECIST criteria. Overall and progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Newly-diagnosed, histologically or cytologically confirmed NSCLC.
- •Inoperable stage IIIA-B disease
- •FEV1 >1.2L
- •No previous RT to chest
- •No serious comorbid condition
- •No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
- •No participation in clinical trial using any investigational drug or device within four weeks prior to study entry
- •No serious complication of malignant condition
- •No previous or concurrent malignancy at other sites except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin
- •Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
- •Hemoglobin > 9.0 Gm/dL WBC count > 4.0x109/L Neutrophile count > 1.5 cells x 109/L, Version 1, May 12, 2010 Platelet count > 100 x 109/L, Creatinine < 1.5 mg/dL Total bilirubin < upper limit of normal (ULN) AST/SGOT < ULN Calcium < ULN
- •Ability to sign informed consent
- •Ability to attend follow-up visits
排除标准
- •Operable disease
- •Metastases to contra-lateral mediastinal lymph nodes
- •Distant metastases
- •FEV1 < 1.2L
- •Previous RT to chest
- •Treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
- •Participation in clinical trial using any investigational drug or device within four weeks prior to study entry
- •Major surgical procedure within two weeks prior to study entry
- •Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis
- •Serious complication of malignant condition
- •Previous or concurrent malignancy
- •Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
- •Hemoglobin < 9.0 Gm/dL WBC count < 4.0x109/L Neutrophile count < 1.5 cells x 109/L, Platelet count < 100 x 109/L, Creatinine > 1.5 mg/dL Total bilirubin > ULN (upper limit of normal) AST/SGOT > ULN Version 1, May 12, 2010 Calcium > ULN
- •Inability to sign informed consent
- •Psychological, familial, sociological or geographical conditions which do not permit regular medical follow-up and compliance with the protocol
研究组 & 干预措施
Valproic acid, Chemoradiotherapy
Other
干预措施: Valproic acid (Drug)
结局指标
主要结局
Toxicity
时间窗: 24 months
次要结局
- Survival(24 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Valproic Acid With Chemoradiotherapy for Pancreatic CancerPancreatic CancerNCT01333631Soroka University Medical Center20
已完成
2 期
Valproic Acid and Carnitine in Patients With Spinal Muscular AtrophySpinal Muscular AtrophyNCT00227266University of Utah94
已完成
2 期
PhII 5-Azacytidine Plus Valproic Acid and Eventually Atra in Intermediate II and High Risk MDSMyelodysplastic SyndromesNCT00439673Gruppo Italiano Malattie EMatologiche dell'Adulto62
招募中
2 期
Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal CancerRas-mutated Metastatic Colorectal CancerNCT04310176National Cancer Institute, Naples200
尚未招募
不适用
Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) in patients with primary untreated adult langerhans cell histiocytosisadult langerhans cell histiocytosisJPRN-UMIN000006016Department of Hematology, International Medical Center, Saitama Medical University5